NIRA Model 2
K-Number: K222685 · 2023-02-08
ApplicantDermal Photonics Corp
Decision Date2023-02-08
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
NIRA Model 2 is a medical device manufactured by Dermal Photonics Corp. It received FDA 510(k) clearance on 2023-02-08 under approval number K222685. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NIRA Model 2?
NIRA Model 2 is a medical device that received FDA 510(k) clearance on 2023-02-08. It is manufactured by Dermal Photonics Corp. The 510(k) number is K222685.
When was NIRA Model 2 approved by the FDA?
NIRA Model 2 received FDA 510(k) clearance on 2023-02-08, under approval number K222685.
What company makes NIRA Model 2?
NIRA Model 2 is manufactured by Dermal Photonics Corp.
What is the FDA product code for NIRA Model 2?
The FDA product code for NIRA Model 2 is OHS.
Related Devices (Code: OHS)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.